FDA 510(k)

MedCAD® AccuPlate® 病患專屬板

K 號：K193280 · 2021-02-12

申請人Medcad

決定日期2021-02-12

產品代碼JEY

諮詢委員會DE

決定相當於

器材摘要

MedCAD® AccuPlate® Patient-Specific Plate is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K193280. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MedCAD® AccuPlate® Patient-Specific Plate?

MedCAD® AccuPlate® Patient-Specific Plate is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Medcad. The 510(k) number is K193280.

When did MedCAD® AccuPlate® Patient-Specific Plate receive FDA 510(k) clearance?

MedCAD® AccuPlate® Patient-Specific Plate received FDA 510(k) clearance on 2021-02-12, under 510(k) number K193280.

Who is the listed applicant for MedCAD® AccuPlate® Patient-Specific Plate?

The FDA 510(k) record lists Medcad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedCAD® AccuPlate® Patient-Specific Plate?

The FDA product code for MedCAD® AccuPlate® Patient-Specific Plate is JEY.

其他以 Medcad 為申請人之記錄

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K252064MedCAD® AccuStride™ 系統 K251709MedCAD® AccuStride™ 系統 K241811MedCAD® AccuStride™ 系統 K230398MedCAD® AccuPlate® 3DTi 為患者量身定製板金系統 K223421MedCAD精準計劃骨科系統 K223024MedCAD精準計劃系統

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相關器械（代碼：JEY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260137KLS Martin IPS 口腔-馬克斯植入物 - MR條件性；個人患者解決方案 - Ti (IPS-Ti)；個人患者解決方案 - PEEK (IPS-PEEK)；KLS Martin 個人患者解決方案KLS-Martin L.P.K253206謹慎個別化CMF解決方案Meticuly Co., Ltd.K252246萊福特MMF系統Jeil Medical Corporation K253373南頸顎面骨系統Southern Medical (Pty) , Ltd.K251441Inion CPS 1.5 婴兒生物可吸收固定系統；Inion CPS 1.5/2.0/2.5 生物可吸收固定系統Inion OY K241314KLS Martin 口腔-馬克斯植入物 MR條件性（組合式）KLS-Martin L.P.

官方來源

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